Audit - 22

Audit Manual 22 - Auditing an Oral Solid Solution Area

Apply the regulatory requirements related to oral dosage forms. Perform an audit of oral dosage forms. Use a range of information tools, from the contents of this unit to the Intranet in support of an audit of oral dosage forms. Recognize compliance or non

Audit 22 - Auditing an Oral Solid Solution Area

Most solid dose forms usually contain five different types of ingredients. The first, the active pharmaceutical ingredient (API), delivers the therapeutic effect. The second chemical, a binder, is added to the batch to hold the solid (tablet/capsule) together. A disintegrator is added to help the body break down the tablet after administration.

Abase, which is an inert substance, may be added to provide size and weight to the tablet. It must be compatible with the active pharmaceutical ingredient and not interfere with the therapeutic action of the active pharmaceutical ingredient. One other ingredient that is normally added is a food grade lubricant that prevents the tablet from being caught or stuck in the tableting press. An optional chemical that may be added is either a dye to give color to the tablet and/or a flavoring.

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